Trial · NCT00418314

FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

NCT00418314, Not applicable, Completed, Abbott Medical Devices; results first posted 2016-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. FREEDOM - A Frequent Optimization Study Using the QuickOpt Method. Trials, record NCT00418314. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00418314

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
NCT number: NCT00418314
Status: Completed
Phases: Not applicable
Enrollment: 1,647 participants, actual
Lead sponsor: Abbott Medical Devices
Conditions: Cardiac Arrhythmias, Heart Failure
Interventions: Control, QuickOpt
First posted: 2007-01-04
Last updated: 2019-02-19
Results first posted: 2016-02-04

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Heart Failure Clinical Composite Score	12 months	The clinical composite score classifies each randomized patient as improved, unchanged, or worse depending on the clinical response during and the clinical status at the end of the trial. Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment (or both) but did not experience any major adverse clinical events during the course of the trial. Patients are considered worse if they experienced a major clinical event during the study duration or reported worsening of their NYHA class or global assessment at the final visit. Patients are considered unchanged if they are neither improved nor worse.
Secondary	All-cause, Cardiovascular and Heart Failure Mortality;	12 months
Secondary	All Cause, Cardiovascular and Heart Failure Hospitalization	12 months

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Heart Failure Clinical Composite Score	12 months		participants	NUMBER
SECONDARY	All-cause, Cardiovascular and Heart Failure Mortality;	12 months	Per protocol	participants	NUMBER
SECONDARY	All Cause, Cardiovascular and Heart Failure Hospitalization	12 months		participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Heart Failure Clinical Composite Score	QuickOpt (Treatment)	Improved	551	participants
Heart Failure Clinical Composite Score	Control	Improved	559	participants
Heart Failure Clinical Composite Score	QuickOpt (Treatment)	Unchanged	76	participants
Heart Failure Clinical Composite Score	Control	Unchanged	86	participants
Heart Failure Clinical Composite Score	QuickOpt (Treatment)	Worsened	189	participants
Heart Failure Clinical Composite Score	Control	Worsened	183	participants
All-cause, Cardiovascular and Heart Failure Mortality;	QuickOpt (Treatment)		44	participants
All-cause, Cardiovascular and Heart Failure Mortality;	Control		42	participants
All Cause, Cardiovascular and Heart Failure Hospitalization	QuickOpt (Treatment)		294	participants
All Cause, Cardiovascular and Heart Failure Hospitalization	Control		303	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	QuickOpt (Treatment)	817
Overall Study	STARTED	Control	830
Overall Study	COMPLETED	QuickOpt (Treatment)	816
Overall Study	COMPLETED	Control	828
Overall Study	NOT COMPLETED	QuickOpt (Treatment)	1
Overall Study	NOT COMPLETED	Control	2

Source ClinicalTrials.gov

Adverse events82

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cardiopulmonary Arrest	Cardiac disorders	QuickOpt (Treatment)	2	816	2
other	Cardiopulmonary Arrest	Cardiac disorders	Control	4	828	4
other	Arrhythmias	Cardiac disorders	QuickOpt (Treatment)	65	816	83
other	Arrhythmias	Cardiac disorders	Control	55	828	63
other	Elevated Pacing Thresholds	Cardiac disorders	QuickOpt (Treatment)	10	816	13
other	Elevated Pacing Thresholds	Cardiac disorders	Control	3	828	3
other	Undersensing/Oversensing	Cardiac disorders	QuickOpt (Treatment)	14	816	16
other	Undersensing/Oversensing	Cardiac disorders	Control	11	828	14
other	Heart Failure	Cardiac disorders	QuickOpt (Treatment)	61	816	95
other	Heart Failure	Cardiac disorders	Control	43	828	63

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	QuickOpt (Treatment)
Total, all-cause mortality	Control
Total, other adverse events	QuickOpt (Treatment)	184	816
Total, other adverse events	Control	177	828
Total, serious adverse events	QuickOpt (Treatment)	120	816
Total, serious adverse events	Control	111	828

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20569704	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
QuickOpt (Treatment) vs Control: All-cause, Cardiovascular and Heart Failure Mortality;	Trial comparisons
QuickOpt (Treatment) vs Control: All Cause, Cardiovascular and Heart Failure Hospitalization	Trial comparisons
QuickOpt (Treatment) vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00418314

GET https://conductscience.org/api/trials/v1/NCT00418314/events?page=2

API reference For AI assistants